EVarQuit: Extended Pre-quit Varenicline to Assist in Quitting Smoking

• Drug: Varenicline
  oral varenicline tablets
  Other Name: Chantix
• Behavioral: Brief smoking cessation counseling
  ~10-minute individual counseling at each of 6 clinic visits

• Experimental: Extended Run-In

  ** 4 weeks of varenicline prior to the target quit date (TQD) **

  + 11 weeks of post-TQD varenicline

  Standard varenicline dosing titration in initial week of therapy (one 0.5 mg tablet orally daily x 3 days, then one 0.5 mg tablet twice daily x 4 days); then 1 mg twice daily thereafter.

  Brief individual counseling at clinic visits

  Interventions:

  • Drug: Varenicline
  • Behavioral: Brief smoking cessation counseling
• Active Comparator: Standard Run-In

  ** 3 weeks of placebo followed by 1 week of varenicline prior to the target quit date (TQD) **

  + 11 weeks of post-TQD varenicline

  Standard varenicline dosing titration in initial week of therapy (one 0.5 mg tablet orally daily x 3 days, then one 0.5 mg tablet twice daily x 4 days); then 1 mg twice daily thereafter.

  Brief individual counseling at clinic visits

  Interventions:

  • Drug: Varenicline
  • Behavioral: Brief smoking cessation counseling

Inclusion Criteria:

• Smoking at least 10 cigarettes per day for the past 6 months and expired-air carbon monoxide (CO) >7 at intake.
• At least moderately motivated to quit smoking and intention to make a quit attempt with varenicline 1 month after treatment begins.
• Planning to remain in western New York (NY) during the study period
• Willing to use varenicline and to refrain from other cessation treatments and tobacco products during the study period.
• English speaker
• To be intent-to-treat (ITT), the participant must complete Lab Visit 1 and meet minimal completion rate for real-world (EMA) assessments.

Exclusion Criteria:

• Use of other tobacco products, including e-cigarettes, in past 7 days
• Use of smoking cessation medication, including nicotine replacement therapy, in the past 14 days
• Prior allergy/hypersensitivity to varenicline
• Pregnant or breast-feeding

• Substance use:

  • Alcohol: AUDIT score > 15 at intake, suggestive of alcohol dependence and warranting treatment; for those with scores between 8 and 15, the investigators will advise reducing drinking).
  • Medical treatment for substance use in past 3 months, including Suboxone (buprenorphine) and methadone (at phone screen)

  • Using a combination of the National Institute on Drug Abuse (NIDA) modified ASSIST (4-26 = moderate risk; 27+ = high risk) and urine toxicology screen (both at intake):

    • Cannabis: ASSIST=27+ (tox screen not used)
    • Cocaine: ASSIST=7+ OR positive tox screen
    • Methamphetamine: ASSIST=7+ OR positive tox screen
    • Inhalants, hallucinogens, sedatives, or sleeping pills: ASSIST score = 7+
    • Prescription stimulants: With prescription, ASSIST 27+; Without prescription, ASSIST 7+
    • Opioids: With prescription, ASSIST 27+ (note ineligible if prescription is for buprenorphine or methadone); Without prescription, ASSIST 7+ OR positive tox screen

(Note: ASSIST 4+ modified to 7+ in 2018 to avoid excluding people with past SU problems. clinicaltrials.gov edited 12/18/18)

• Psychiatric:

  • Antipsychotic medications
  • Lifetime history of schizophrenia or bipolar disorder
  • Evidence of current major depression (per Patient Health Questionnaire (PHQ-9) at intake
  • Past 10 years suicidal ideation (SI) / behavior. At intake, all of the following are exclusionary on the baseline Columbia-Suicide Severity Rating Scale (Posner et al., 2008): SI without intent (C-SSRS #1, #2, or #3), if any intensity rating (Frequency, Duration, Controllability, Deterrents, or Reasons for Ideation) is > 2; SI with intent (C-SSRS #4, or #5), regardless of intensity ratings; Suicidal Behavior (any suicide attempt, interrupted attempt, aborted attempt, or suicide preparatory acts or behavior on the C-SSRS).
• Any medical condition, illness, disorder or concomitant medication that compromises participant safety or treatment, as determined by the Principal Investigator and/or Study Physician.
• Inability to provide informed consent or complete any of the study tasks as determined by the Principal Investigator and/or Study Physician.

• National Cancer Institute (NCI)
• Pfizer